Caring for BRAIN pioneers: Understanding and enhancing family and researcher support in neural device trials

项目摘要 大脑先驱者是那些承担重大风险的人，他们是第一次参与人类或早期研究的人。 神经技术研究是为了帮助科学的发展。他们愿意尝试侵入性的和非侵入性的- 医疗必需的设备，他们投入的大量时间和精力，以及他们与 研究团队通常是经过3-5年的密集实验建立起来的，这使得他们在研究中相对独特。 参与者他们的幸福是神经技术领域持续发展的组成部分，然而， 相对较少的神经伦理学的注意力集中在支持的结构，从研究人员和 家庭成员，使大脑的先驱，成功地参与神经设备试验。在本研究中， 我们：1）利用嵌入式伦理学家观察参与者之间的互动，长期，可植入 神经装置试验，他们的家庭伙伴，和研究小组，以确定护理和支持提供的模式 2）使用定性访谈来探讨参与者，家庭成员和 研究人员阐明了家庭和研究人员护理和支持的作用，好处和局限性， 试验期间和试验后;以及3）为更包容的支持制定最佳实践建议 研究设计和实践中的结构。

Project abstract BRAIN pioneers are people who take on significant risk as participants in first-in-human or early neurotechnology studies for the sake of helping to further science. Their willingness to try invasive and non- medically necessary devices, their investments of significant time and energy, and their close relationships with study teams, typically built over 3-5 years of intensive experiments, make them relatively unique as research participants. Their well-being is integral to the continued development of the field of neural technology, yet relatively little neuroethical attention has been focused on the structures of support, from researchers and from family members, that enable BRAIN pioneers to successfully participate in neural device trials. In this study, we: 1) Utilize an embedded ethicist to observe interactions between participants in long-term, implantable neural device trials, their family partners, and the research team to identify modes of care and support provided in the experimental setting; 2) Use qualitative interviewing to explore how participants, family members and researchers articulate the role, benefits, and limitations of family and researcher care and support before, during, and after a trial; and 3) Develop recommendations for best practices for a more inclusive support structure in research design and practice.